Operations Manual DENAS CARDIO

TRONITEK LLC , Ekaterinburg, Russia

Trancutaneous electrostimulator for

impact on biologically active zones

Operations Manual

DENAS® ®CARDIO

ТRТК 05.0-03.70-05 РЭТU 9444-005-44148620-2006Registration certificate of the Federal Service on Surveillance in Healthcare (Roszdravnadzor) № FSR 2011/11772

Россия/Russia

ЕС, все страны/

EU, all

США/USA

Канада/Canada

Extract

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CONTENTS

2. Function....................................................................73. Complete Set and Apparatus Arrangement.................154. Order of Treatment...................................................185. Technical Maintenance.............................................256. Order of Replacing the Power Source......................267. Troubleshooting List................................................288. Specifications.........................................................309. Guarantees of the Manufacturer...............................3810. Coupon for Warranty Repair. ..................................41

Certificate of Acceptance.......................................43

1. Safety Measures...........................................................3

11.

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1 SAFETY MEASURESRead all the information in the present manual care-fully! The manual contains important information of your safety as well as recommendations of correct usage and unit care.

The apparatus is not electrically dangerous for the patient due to its built-in low voltage electric power source, isolated from the operational part of the apparatus (device of BF type)

The apparatus must not be used for treating pa-tients with implanted electronic devices (for exam-ple, cardiostimulator) and for treating patients with individual electric current intolerance.

The apparatus must not be used in the area of direct projection of the heart on the front of the body.


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During stimulation the patient must not be con-nected to any high-frequency electric device, si-multaneous application of the apparatus and an-other electric device can result in burns and pos-sible damage of the apparatus.

Operation in the close proximity to shortwave or mi-crowave equipment may produce instability in the stimulator output.

The apparatus contain fragile elements. Keep it from blows and drops.

Warning! Do not use the unit on damaged skin, as well as the presence of signs of inflammations of the skin

It is prohibited to use of external power supply network.


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Conditions of transportation: temperature from – 50 to + 50°C, relative air humidity from 30 to 93%, at-mospheric pressure from 70 to 106 kPa

Conditions of storage: temperature from – 50 to + 40°C, relative air humidity from 30 to 93%, atmos-pheric pressure from 70 to 106 kPa

Operation conditions: ambient air temperature from 100C to 350C, relative air humidity from 30 to 93%, at-mospheric pressure from 70 to 106 kPa.If the apparatus is stored at the temperature below 100C, keep it under normal conditions at least for two hours before use.

The apparatus is not waterproof. Protect it from wa-ter.

All the repair works for the apparatus shall be car-ried by qualified personnel of the manufacturer.


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Recycling:All the package materials are environmental-friend-ly and can be reused.Separate assemblage of electric and electronic equipment.

The old apparatus is not useless garbage! It contains val-uable materials, which can be recycled in compliance with rules on environmental protection. Hand them to specially assigned centers for collection and recycling (consult your district authorities).


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2 FUNCTION

The DENAS-CARDIO apparatus is intended for thera-peutic non-invasive (without damaging the skin surface) course treatment of biologically active zones by the method of dynamic electrostimulation for correction of the arterial blood pressure (AP) and normalization of the general state of health. The apparatus is intended for peo-ple of over 14 years of age with a labile form of the arterial hypertension and patients with a lasting increase of the ar-terial blood pressure (essential hypertension) as an addi-tional treatment on the background of drugs taken.

The DENAS-CARDIO apparatus combines frequencies9.2, 8.1, 3.3, 77, 20, 10 Hz which are traditionally applied fortreatment of hyper-tension and a specially developed mode “77 10” intended for producing a general sedative, calming effect.

Electrostimulation with the “DENAS-CARDIO” appara-tus promotes normalization of the vessel wall, dilatation of capillaries, and improvement of hemodynamics in the sys-tem of cutaneous microcirculation.

2.1 General information


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As a result of these:— arterial pressure is being stabilized at the level accept-

able for a patient;— cenesthesia improves;— psycho-emotional state improves;— physical efficiency increases;— the risk of complications of the essential hypertension

is reduced;— quality of the patient’s life improves.The DENAS-CARDIO apparatus is intended for course

treatment of patients with arterial hypertension as an additional treatment on the background of basic drug therapy.Attention! Even in cases of situational (single, seldom)

increase of the arterial blood pressure a coursetreatment of not less than 10 procedures is necessary, 1-2 procedures daily. Meanwhile, in the beginning of treatment a temporary destabilization of the arterial blood pressure with its further stable reduction may be observed.


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Apparatus treatment has an effect of “accumulation” that is AP becomes stable by the end of the treatment course.

The procedure is to be carried out 1-2 times daily, bet-ter in one and the same time of the day regardless of the AP level before the procedure.

Patients with essential hypertension need repeated reg-ular treatment courses minimum once a month (for instance from the first to the 15th day of each month).

There is no need to control AP after the pro-cedure.

In compliance with international recommendations, it is recommended for patients with essential hypertension to keep a “journal of AP” and measure arterial blood pressure three time a day at one time (morning, afternoon, evening), even if the patient feels good. In case of any complaints (headache, vertigo, pain in the heart, intermission in the heart work, weakness, syncopal state and

2.2 Application

Attention!


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others) an additional measurement of AP is needed.

During the treatment with the “DENAS-CARDIO” it is forbidden that the patient with aconsiderable increase of AP and high risk of vascular complications (myocardial infarction, cerebral stroke, thromboembolism) stops taking the drugs him/herself on the background of treatment with the “DENAS-CARDIO”apparatus. After having a stable hypotensive effect registered in the “jour-nal of AP”, regimes and doses of drug treatment may be changed by the attending doctor.

Patients with seldom periodical and slight increase of the arterial blood pressure (not higher than 150 mmHg) – labile arterial hypertension – can apply the “DENAS-CARDIO” apparatus as monotherapy. Such an approach can retard and prevent the disease from converting into a stable form.

Warning!


— stable high arterial blood pressure of patients with essen-tial hypertension – as an addition to complex drug treatment;

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2.3 Indications for application:

— episodic increase of AP under stressful situations, changes of weather conditions and so on in patients with a labile form of arterial hypertension.

2.4. Recommendations for application of the “DENAS-CARDIO” apparatus for course treatment: carry out 1-2procedures a day during 10-15 days regardless of the AP indices before the procedure. With a stable form of arterial hypertension, repeat the courses monthly.

2.5. Recommendations for one-time application of the “DENAS-CARDIO” apparatus for persons with susceptibility to AP increase under ill-being: take a hypo-tensive medicine recommended by your attending doctor and additionally carry out treatment procedures with the “DENAS-CARDIO” apparatus every 1-1.5 hours until thecomplaint is eliminated. In case of long-lasting high arterial blood pressure, address the doctor.


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2.6. Recommendations for application of the “DENAS-CARDIO” apparatus for patients older than 70 years of age:in the advanced age a slower rate of AP reduction. For this a recommended order of treatment with the “DENAS-CARDIO” is once a day. Treatment course – not morethan 7-8 procedures. It is advisable to repeat the treatment course after 10-15 days break.

During first treatment course, AP can fluctuate a little that’s why the patient shall continue taking the hypotensive medicines prescribed by the doctor.

2.7 Recommendations for application of the “DENAS-CARDIO” apparatus for patients with malignant hy-pertension: malignant hypertension is a stable high arte-rial blood pressure, more than 180 mmHg that cannot be treated with drug correction under correct and systematic taking of drugs: course duration and number of procedures per day shall be determined after consulting an attending doctor.


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Absolute:— individual intolerance to the electric current;— implanted cardiostimulator;Relative — in these cases it is recommended to use the

electrostimulator only after consulting your attending doc-tor:

— epileptic seizure;— neoplasms of any etiology and localization;— acute febrility of unclear etiology;— vein thrombosis— condition of acute psychic excitement, alcoholic or

drug intoxication;On the background of application of the “DENAS-CARDIO” apparatus taking the drugsprescribed by the doctor is obligatory! Changing the regimes of medical treatment and reduction of doses of the drug to be taken is allowed after stable reduction of AP and after consulting your

2.8 Contraindications to application:

Warning!


attending doctor only.

There are no trials of DENAS-therapy for pregnant women, so the device should be used only in case of absolute necessity with the specialist consultations.

Warning!

In the case of deterioration of the health when using the machine, refer to a specialist.

Warning!

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3 COMPLETE SET AND APPARATUS ARRANGEMENT

Apparatus body

Display

Cover of the power source compartment

ON/OFF button

Cuff

CaseBatteries LR6/AA, 1.5 V type

Operations Manual

Program button


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Symbols of the display:

Indication of a contact with the skin and the phase of treatment program

Displaying the number of treatment program

The "battery low"

– The skin contact is set, the first step of program is performed;

– The skin contact is set, the second step of program is performed;

– The skin contact is set, the third step of program is performed;

– The skin contact is set, the procedure is finished.


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To avoid breaking the case, fold the cuff of the apparatus in a correct way!

Step 1. Pass the end of the cuff through the loop.

Step 2. Fold the cuff around the apparatus body that the lock ele-ment of cuff be on the side of the-cover of the power source compart-ment

Step 3. Place the apparatus into the case

Attention!


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5 TECHNICAL MAINTENANCE

5.1 Daily technical maintenance should include the fol-lowing:— external examination of the apparatus;— disinfection of electrodes.Use standard disinfection means and soft napless nap-kins to clean the electrodes.5.2 Check of service ability of the apparatus in accord-ance with instructions in Section 4.5.3. If the apparatus is supposed not to be used for a longperiod, remove the power source from its compartment (Section 6).5.4. Having noticed the symbol on the indicator, re-place the power source (Section 6).


Manufacturer's address:TRONITEK, LLC Academica Postovsky St. 15, Ekaterinburg 620146, Russia

Official webstores of Denas MS Corporation:Denas Store www.denas-store.comDenas Health Store www.denashealthstore.comE‐mail: [email protected]

40www.denas-store.com & www.denashealthstore.com

41

ENRU

10 ТАлОН НА ГАРАНТИйНый РЕмОНТCOUPON FOR WARRANTY REPAIR

Наименование: ДЭНАС-КАРДИОName: DENAS-CARDIOСерийный номер изделияSerial No.____________________________________________ Дата изготовления / Date of manufacture_______________ Дата покупки / Date of selling__________________________ Владелец / Customer__________________________________Адрес / Address:______________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________Телефон / Phone____________________ домашний / home ______________________________________рабочий / officeДата отправки в ремонтDate of sending for repair______________________________


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RU ENПричина отправки в ремонтReason for repair_______________________________________________________________________________________________________________________________________________Отметка о ремонтеNote about repair______________________________________

подпись должностного лица предприятия, ответственного за приемку после ремонта

Signature of the official responsible for acceptance after repair

Изделие проверено, претензий к комплектации, внешне-му виду не имею. The apparatus was checked, I have no claims to the com-plete set, appearance of the apparatusПодпись покупателяSignature of the customer______________________________Дата получения / Date________________________________Гарантия на отремонтированное изделие составляет 12 месяцев с момента получения изделия из ремонта. В случае, если гарантийный срок с момента приобретения изделия составляет более 12 месяцев, то гарантия исчисляется по большему сроку. А также гарантийный срок увеличивается на время нахождения изделия в ремонте.Warranty to the repaired apparatus is 12 months from the date of taking the apparatus from the service center. In case the warranty period from the moment of selling is more than 12 months, the warranty period shall be calculated with a longer period. The warranty period will also increase for the period of repair.


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ENRU11 СвИДЕТЕльСТвО О пРИЕмКЕ CERTIFICATE OF ACCEPTANCE Электростимулятор чрескожный для воздействия на

БАЗ «ДЭНАС-КАРДИО»Transcutaneous electrostimulator for stimulation of

biologically active zones DENAS-CARDIOЗаводской номерSerial No.__________________________________________Соответствует требованиям ТУ 9444-005-44148620-2006

и признан годным для эксплуатации.Complies with the standards TU 9444-005-44148620-2006

and is acknowledged to be ready for operation.

Дата изготовленияDate of manufacture________________________________

Подпись должностного лица предприятия, ответственного за приемкуSignature of the official responsible for acceptance__________________________


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RU ENДата продажиDate of sale________________________________________

Подпись продавцаSignature of the shop assistant_______________________

С условиями гарантии ознакомлен, изделие про-верено, претензий к комплектации, внешнему виду не имею.

I received information about warranty conditions, the ap-paratus was checked, and I have no claims to the complete set, appearance of the apparatus

Подпись покупателяSignature of the customer___________________________


Documents

Operations Manual DENAS CARDIO